Great questions elicit enlightening answers. Especially when the first come from a wise moderator (Brendan Crowley, President, Brendan Crowley Advisors LLC), and the second a seasoned industry veteran (Remo Colarusso, Vice President, Janssen Supply Chain, Johnson & Johnson). Here’s what they had to say about drug development and manufacturing partners.
Chief Editor’s Note: An Outsourced Pharma reader asked if we could do an article on the handling of incoming bulk drug substance: "The regulations are fuzzy, at best, and I haven’t been able to find any articles recently that cover the topic.” One of our contributing authors, Bikash Chatterjee, took on the challenge …
FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.
This article emphasizes the importance of implementing a regular routine maintenance for inductively coupled plasma mass spectrometry (ICP-MS) equipment, so problem areas associated with instrumental components that are most susceptible to sample blockage, drift, and signal instability can be avoided.
The use of monoclonal antibodies (MAbs) and MAb conjugates as biopharmaceuticals have increased over the last decade. As a result, more cost-effective, efficient, and flexible process purification solutions are of high priority for MAb manufacturers. Increasing product titers upstream can introduce challenges in downstream purification processes. With increased MAb titers, the cell culture supernatant might contain an elevated number of impurities (e.g., aggregates) that need to be separated from the target molecule.
The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont
Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.
Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them.
Capto S ImpAct chromatography medium (resin) is a strong cation exchanger (CIEX). The medium is designed for the polishing steps of monoclonal antibodies (MAbs) and a wide range of other biomolecules.
The growing public awareness of a potential pandemic requiring rapid treatment of millions of healthy individuals has spurred renewed interest in vaccines. Vaccine development timelines vary from being only a fraction of other biotherapeutics to decades of research and efforts to find an effective vaccine. Vaccination campaigns mean that often very large quantities need to be manufactured, maintained, and distributed.
This application note demonstrates the performance of Capto Core 700 chromatography medium (resin) as an alternative for ovalbumin removal in the production of egg-based influenza vaccine.
A commercial stage medical technology company has developed SMART Softgels featuring a special shell to release quickly while still preventing evaporative loss during and after manufacturing.
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From discussions with pharmaceutical and biotechnology industry leaders, it is clear that demand forecasting is a significant challenge when planning biologic drug substance production.
By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.
In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.
In June 2016, Alvotech opened their new biosimilar manufacturing facility in Reykjavik, Iceland, using best of breed solutions from leading Life Science vendors. The key directive for Alvotech was to create a flexible, agile process which could adapt and be used for any conceivable process. The result: A high yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes, tied together with a complete, end-to-end upstream/downstream automation and Manufacturing Execution System.
Though pharma companies do their best to understand the environment, it can be very difficult to predict demand, and the consequences of incorrect forecasts can be very costly in a number of ways.